Care of the Urothelial Cancer Patient and Prospective Procurement of Urothelial Cancer Tissue

NCT ID: NCT02379429

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-10
• Study Completion Date: 2028-01-01

Brief Summary

Background:

Urothelial cancer is cancer of the bladder, ureter, and urethra. Researchers want to better understand what changes in a person s cells and genes cause this cancer to form. This may help them find new ways to treat it.

Objective:

• To perform DNA sequencing to help researchers learn the differences between normal tissue and tumor tissue. Also, to learn how molecular changes - including gene changes - might help predict the course of disease and how people respond to therapy.

Eligibility:

• Adults age 18 and older who have or are suspected of having urothelial cancer or an inherited disorder that raises their risk of getting bladder cancer.

Design:

• Participants will be screened with a physical exam. Their medical records and tissue samples will be reviewed.
• Eligible participants will give tissue blocks of their original tumor. The blocks will be put in a tissue bank.
• Participants medical records may be reviewed.
• Participants may have a medical history and physical exam.
• Participants may have blood and urine tests. They may have imaging scans. They may give urine, blood, and saliva samples. These samples may be used in future research.
• If participants need surgery for their cancer, researchers will keep some of the tissue (both tumor and normal tissue). The tissue may be used in future research.
• Participants will go back to the Clinical Center in 6 months. They may give saliva, urine, and blood samples. After 6 months, they will be seen by their local doctor for standard post-surgical visits.
• Participants will be called every 6 months to give health updates.

Detailed Description

Background:

• Urothelial carcinoma, present as lower or upper urinary tract disease, is the most expensive malignancy to treat from diagnosis to death, and no major advances in drug therapy have taken place in the last two decades.
• Understanding the molecular mechanisms and genomic alterations that cause urothelial carcinoma will provide the foundation for the development of novel targeted therapeutic agents for this disease. Since 1982 investigators in the Urologic Oncology Branch have been studying the genetic basis of urologic cancers. The identification of the genes for cancer of the kidney has led to the approval by the FDA of a number of new agents for patients with advanced disease. Similarly, it is our goal to study the cancer biology (genomic, molecular, and cellular biology) of urothelial carcinoma in order to develop novel treatment strategies.
• Collection of patient tumor samples allows us to study molecular and biologic pathways and develop novel targeted therapies. Correlation of these samples with clinical outcomes in patients allows us to predict and understand clinical outcomes and possibly develop predictive and/or prognostic biomarkers.
• Collection of blood, urine and saliva from healthy volunteers will allow us to distinguish normal and inflammatory conditions from malignant diseases. Furthermore, the specimens will provide appropriate controls for comparison.

Objective (Primary):

• Collect blood, urine, and benign and malignant tissue from patients with known or suspected urothelial cancer for the purpose of elucidating the molecular mechanisms of carcinogenesis in urothelial cancer and ultimately, identifying novel therapeutic targets.
• Collect blood, urine and saliva from healthy volunteers for the purpose of establishing controls for comparison with urothelial cancer specimens.

Eligibility:

• Adults with biopsy-proven or suspected urothelial cancer who require diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or followup/surveillance for their neoplasm.
• Healthy volunteers from whom blood, saliva and urine samples are easily obtainable.

Design:

• Care of the patient with urothelial carcinoma will be provided as per medically indicated standards and in the process, normal and malignant urothelial cancer tissues may be obtained at the time of clinically indicated diagnostic and/or therapeutic intervention.
• Blood, urine, and saliva samples for research may be obtained from patients and healthy volunteers at baseline. Additionally, blood and urine may be collected from patients at follow-up intervals.
• No investigational or experimental therapy will be given as part of this protocol.

Conditions

Bladder Cancer; Urinary Tract Cancer; Urothelial Cancer; Healthy Volunteers

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1/Participants

Adults with biopsy-proven or suspected urothelial cancer who require diagnostic or therapeutic intervention

No interventions assigned to this group

2/Healthy Volunteers

Healthy volunteers from whom blood, saliva and urine samples are easily obtainable.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adults (>= 18 years of age) with biopsy-proven or suspected urothelial cancer who require and are willing to undergo diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up/surveillance for their neoplasm.
• ECOG performance status of 0-3.
• Must be willing and able to provide informed consent.

-Adults (greater than or equal to 18 years of age) and able to give informed consent.

Exclusion Criteria

• Subjects who are pregnant.
• Subjects co-morbidities preclude diagnostic or therapeutic intervention. Co-morbidities include:

--Ongoing treatment for another non-skin malignancy.

• History of hepatitis B/C or HIV. Patients who are HIV positive are excluded from this study because treatment with immunomodulatory agents for immunosuppressed patients would affect sample analysis and skew the data.

ELIGIBILITY CRITERIA FOR HEALTHY VOLUNTEERS

• Subjects who are pregnant.
• Diagnosis of cancer requiring treatment other than minor resection of basal cell or squamous cell skin cancers.
• Heart, lung, kidney disease, or other medical conditions as per Principal Investigator discretion.
• History of acute or chronic hepatitis B/C or HIV infection. Patients who are HIV positive are excluded from this study because treatment with immunomodulatory agents for immunosuppressed patients would affect sample analysis and skew the data.
• Healthy volunteers who are family members with germline mutations.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raju R Chelluri, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lidenys C O'Brien Gutierrez

Role: CONTACT

lidenys.o'brien@nih.gov

(240) 858-7481

Raju R Chelluri, M.D.

Role: CONTACT

raju.chelluri@nih.gov

(240) 858-3700

Facility Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

Role: primary

ccopr@nih.gov

800-411-1222 ext. TTY dial 711

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2015-C-0087.html

NIH Clinical Center Detailed Web Page

Other Identifiers

15-C-0087

Identifier Type: -

Identifier Source: secondary_id

150087

Identifier Type: -

Identifier Source: org_study_id